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Herceptin, one of the world’s well-known blockbuster drugs are under the attack of biosimilar developers in the recent years.

Herceptin (trastuzumab) is a humanized monoclonal antibody which is designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential.

Herceptin was developed by Genentech (now a member of Roche group) and as we are close to the patent expiry of this blockbuster, lots of biosimilar manufacturers are trying to develop their own versions.

But of course, Roche (and Genentech) is trying to develop new molecules like pertuzumab and also conducting clinical studies of a subcutaneous (SC) formulation of Herceptin to have a very big competitive advantage over possible biosimilars.

HannaH study, which is still ongoing, is an open-label study involving 596 women with HER2 positive early breast cancer. The study was designed to compare trastuzumab in the blood, efficacy and safety of Herceptin SC to that of Herceptin IV.

In October, Roche announced that, the study met its co-primary endpoints which were trastuzumab concentration in the blood (serum concentrations) and efficacy. Secondary endpoints included event-free survival and overall survival. In the study the most common side effects seen were infections and abnormal blood counts (anaemia and low white blood count).

Herceptin SC uses the Enhanze™ Technology, developed by Halozyme Therapeutics, Inc. which enables the injection of large volumes of a medication under the skin (subcutaneous). It works by reversibly breaking down a gel-like substance (hyaluronan) that forms a barrier in the tissues between cells under the skin.

Since 1998, Herceptin has been used to treat almost one million patients with HER2-positive breast and stomach cancer worldwide and is approved in more than 150 countries.

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